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Medical device makers give FDA official an earful

The federal official who oversees the review and approval of medical devices came to the Twin Cities Tuesday, to hear what industry leaders and medical experts have to say about how the agency is doing its job. They aired a host of complaints.

The medical device industry employs some 50,000 people in Minnesota. Medtronic, St. Jude Medical and other medical device companies headquartered here do tens of billions of dollars in sales each year.

So, it's not surprising that some 550 people showed up for the town hall-style meeting with Jeffrey Shuren of the Food and Drug Administraion. Shuren is director of the FDA's Center for Devices and Radiological Health, the agency that decides if devices such as pacemakers and stents can be sold for use in patients.

Shuren heard lots of complaints about the FDA's review process.

Dr. John Sherman said he was medical director of a company developing treatments for spinal injuries. But he said the FDA approval process drove away investors. They were worried about putting money into a product that the FDA might not approve for a long time, if ever.

Sherman said that uncertainty was fatal for the company.

"It was shut down primarily because of some of the lack of predictability surrounding the FDA," said Sherman. "This is tremendously innovative technology. I would argue it was probably some of the most innovative technology I have ever seen as a spine surgeon."

The FDA also heard from unhappy venture capitalists -- the folks who fund most medical device startup companies, that may have great ideas but may be years away from sales or profits.

Peter McNerney, a prominent Twin Cities medical technology venture capitalist, said investors are shying away from upstart med tech companies because the FDA approval process is too hard to gauge, and too likely to shoot down new products.

"The regulatory process has become long and uncertain, and in many instances unnecessarily burdensome," he said. "As a result, we have lost our ability to evaluate regulatory risk."

Nationwide, McNerny said venture capital investment in medical device companies declined by more than one-third over the past two years.

Dan Mans, a regulatory consultant for the Minnesota Medical Device Alliance, said the rate of FDA approvals has slowed considerably in the past year.

The FDA says it hasn't been hitting its targets for the length of device reviews. But it says most reviews are getting done according to FDA guidelines.

Some folks wonder if there really is a problem with the FDA approval process for medical devices -- or not.

"My concern is we are doing a 'ready, fire, aim.'
We don't understand if there are substantive problems," said Ralph Hall from the University of Minnesota Law School.

Hall said he has a grant to look at medical devices that got to market and had something go wrong with them. He said he hopes to ascertain if they show the FDA is too lax or appropriately diligent in reviewing medical devices.

"Let's make sure we have the data before we start making substantive changes," he said.

The FDA's Shuren assured the audience he would continue to listen to industry concerns. He spoke of developing a "smart FDA," that better balances safety with innovation.

"At certain times in the past, the pendulum has swing far to one side or the other," Shuren said. "To fulfill our mandate we must embrace both parts of our mission -- that is what it means to truly take a balanced public health approach."

Shuren said he wants to make it easier for companies regulated by the FDA to understand why the agency does what it does, and how decisions are made.

In coming weeks, the FDA will issue a report about possible changes in its device review standards and process. Shuren said he welcomes industry and public input.